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    FDA Registration Active 🇺🇸 United States

    RENASYS GO Home Healthcare User Manual

    Reg #: 1643264 · FEI: 1643264 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SMITH & NEPHEW INC.
    Registration Number
    1643264
    FEI Number
    1643264
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    ENDOSCOPY, 76 S. MERIDIAN AVE.
    City
    OKLAHOMA CITY
    State
    OK
    ZIP
    73107
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152163

    Owner / Operator

    Firm Name
    Smith & Nephew, Inc.
    Operator Number
    1020279
    Address
    2875 Railroad Street
    City
    Pittsburgh
    State
    PA
    Postal Code
    15222
    Country
    US
    Correspondent
    Lisa Ewing

    Products

    Device Name Product Code
    Negative Pressure Wound Therapy Powered Suction Pump OMP

    Proprietary Names

    RENASYS GO Home Healthcare User Manual RENASYS GO Clinical Manual RENASYS GO Carry Strap RENASYS GO Canister 300ml RENASYS GO Rubber Feet RENASYS GO Quick Reference Guide RENASYS GO Power Supply RENASYS GO Carry Case RENASYS GO 'O' Ring RENASYS GO Odor Filter RENASYS GO Pump RENASYS GO Canister 750ml

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)